510(k) K023693
K023693 is an FDA 510(k) premarket notification submitted by Airex, Inc. for the device "MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100". The FDA issued a decision of Substantially Equivalent on March 12, 2003. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2003
- Date Received
- November 1, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type